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The Effect of Preoperative Walking Exercises on the Prognosis of Supratentorial Brain Tumours Patients After Craniotomy

Primary Purpose

Supratentorial Brain Tumor, Exercise, Cognition

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Walking exercise
Sponsored by
Xiangya Hospital of Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Supratentorial Brain Tumor

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The participants voluntarily joined this trial and signed the informed consent form, and were able to comply with the research procedures. Male and female outpatients or inpatients aged between 18 and 65 years. Patients diagnosed with supratentorial tumors through medical history, physical examination, laboratory tests, and head imaging examinations, and without symptoms of intracranial hypertension or epilepsy. Low-risk elective surgery patients with a preoperative waiting period of more than three to four weeks, depending on the actual medical condition and patient preferences. Exclusion Criteria: Patients whose movement may lead to tumour stroke or brain herniation. Patients with a clinical diagnosis of cerebral haemorrhage or intracranial infection or epilepsy. Patients with acute or unstable heart disease (e.g. unstable angina or severe aortic stenosis). Patients with a physical status of Grade 3, 4 or 5 according to the American Society of Anesthesiologists classification. Patients with disabling orthopaedic or neuromuscular conditions. Patients with a history of clinically diagnosed cognitive impairment, such as dementia and mental retardation. Patients with a current or previous diagnosis of significant mental illness, chronic neurological disease or active substance abuse (as per the Diagnostic and Statistical Manual of Mental Disorders 5th edition). Patients with heart failure (New York Heart Association Class 3 or Class 4 functional class). Patients with severe chronic obstructive pulmonary disease (exertional expiratory volume in the first second of exhalation < 50% of predicted value). Patients with anaemia (symptomatic or haematocrit < 30%). Patients who have participated in other trials 1 month before or during the trial. Patients who are prohibited from exercising without face-to-face supervision as assessed by the Physical Activity Readiness Questionnaire (PAR-Q) or as judged by the exercise physician based on the cardiopulmonary exercise testing (CPET). Patients who are unable to cooperate during the Montreal Cognitive Assessment (MoCA) test due to impaired consciousness or mental impairment.

Sites / Locations

  • Xiangya Hospital of Central South UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Walking exercise

Control

Arm Description

Patients receive routine care and exercise as required.

Patients receive only routine care.

Outcomes

Primary Outcome Measures

Incidence of postoperative cardiopulmonary complications (ventricular arrhythmia, pneumonia, atelectasis, etc. [by Japan Clinical Oncology Group postoperative complications criteria])
Type and number of surgery-related cardiopulmonary complications that occurred after the patient's surgery
Cognitive function change (by Montreal Cognitive Assessment [MoCA])
The gap between patients' post-operative and pre-operative cognitive function

Secondary Outcome Measures

Full Information

First Posted
June 19, 2023
Last Updated
October 9, 2023
Sponsor
Xiangya Hospital of Central South University
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1. Study Identification

Unique Protocol Identification Number
NCT05930288
Brief Title
The Effect of Preoperative Walking Exercises on the Prognosis of Supratentorial Brain Tumours Patients After Craniotomy
Official Title
The Role of Short-term Preoperative Walking Exercises in Protecting Cognitive Function and Reducing the Incidence of Surgery-related Complications in the Short Term After Craniotomy in Patients With Supratentorial Brain Tumours
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
April 1, 2026 (Anticipated)
Study Completion Date
April 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xiangya Hospital of Central South University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this clinical trial is to learn about in patients with supratentorial brain tumours. The main questions it aims to answer is: Can short-term preoperative walking exercise protect cognitive function in the short term after craniotomy in patients with supratentorial brain tumor and reduce the incidence of surgery-related complications? Participants will be asked to receive general care and regular walking exercises prior to surgery. Researchers will compare patients who receive only general care before surgery to see if preoperative walking exercise has an effect on postoperative prognosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Supratentorial Brain Tumor, Exercise, Cognition, Postoperative Complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Walking exercise
Arm Type
Experimental
Arm Description
Patients receive routine care and exercise as required.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients receive only routine care.
Intervention Type
Behavioral
Intervention Name(s)
Walking exercise
Intervention Description
The target physical activity level for participants is to walk 10,000 steps per day and to meet or exceed that level (but not exceed 15,000 steps) seven days a week for three to four weeks. Participants will be advised to gradually increase their daily step count in proportion to their physical condition. Exercise will be performed by brisk walking or jogging using the indoor treadmill equipped by the Neurosurgery Department of Xiangya Hospital or outdoors. Each workout will begin with a 5-minute warm-up and end with a 5-minute cool-down.
Primary Outcome Measure Information:
Title
Incidence of postoperative cardiopulmonary complications (ventricular arrhythmia, pneumonia, atelectasis, etc. [by Japan Clinical Oncology Group postoperative complications criteria])
Description
Type and number of surgery-related cardiopulmonary complications that occurred after the patient's surgery
Time Frame
1 week post-operative/discharge
Title
Cognitive function change (by Montreal Cognitive Assessment [MoCA])
Description
The gap between patients' post-operative and pre-operative cognitive function
Time Frame
1 week post-operative/discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The participants voluntarily joined this trial and signed the informed consent form, and were able to comply with the research procedures. Male and female outpatients or inpatients aged between 18 and 65 years. Patients diagnosed with supratentorial tumors through medical history, physical examination, laboratory tests, and head imaging examinations, and without symptoms of intracranial hypertension or epilepsy. Low-risk elective surgery patients with a preoperative waiting period of more than three to four weeks, depending on the actual medical condition and patient preferences. Exclusion Criteria: Patients whose movement may lead to tumour stroke or brain herniation. Patients with a clinical diagnosis of cerebral haemorrhage or intracranial infection or epilepsy. Patients with acute or unstable heart disease (e.g. unstable angina or severe aortic stenosis). Patients with a physical status of Grade 3, 4 or 5 according to the American Society of Anesthesiologists classification. Patients with disabling orthopaedic or neuromuscular conditions. Patients with a history of clinically diagnosed cognitive impairment, such as dementia and mental retardation. Patients with a current or previous diagnosis of significant mental illness, chronic neurological disease or active substance abuse (as per the Diagnostic and Statistical Manual of Mental Disorders 5th edition). Patients with heart failure (New York Heart Association Class 3 or Class 4 functional class). Patients with severe chronic obstructive pulmonary disease (exertional expiratory volume in the first second of exhalation < 50% of predicted value). Patients with anaemia (symptomatic or haematocrit < 30%). Patients who have participated in other trials 1 month before or during the trial. Patients who are prohibited from exercising without face-to-face supervision as assessed by the Physical Activity Readiness Questionnaire (PAR-Q) or as judged by the exercise physician based on the cardiopulmonary exercise testing (CPET). Patients who are unable to cooperate during the Montreal Cognitive Assessment (MoCA) test due to impaired consciousness or mental impairment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhixiong Liu, MD
Phone
+86-13607318785
Email
zhixiongliu@csu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fangkun Liu, MD
Organizational Affiliation
Xiangya Hospital of Central South University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhixiong Liu, MD
Phone
+86-13607318785
Email
zhixiongliu@csu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Due to protect the patients' privacy, the investigators will not make individual patient data (IPD) publicly available. Other researchers intending to obtain IPD may contact the investigators to make a request. The investigators may share IPD if the request is approved by the Ethics Committee.

Learn more about this trial

The Effect of Preoperative Walking Exercises on the Prognosis of Supratentorial Brain Tumours Patients After Craniotomy

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